Kornimate/medical-research-clean huggingface dataset:
predicting the outcome after treatment of meniscal tears

Conditions: Meniscus Lesion; Surveys and Questionnaires

Summary: in this study the investigators examined the ability of orthopaedic surgeons to predict the outcome of surgery and non-operative treatment in patients (age 45 to 70) with a non-obstructive meniscal tear.

the additional benefits of arthroscopic partial meniscectomy (apm) in middle aged patients with a non-obstructive meniscal tear are under scrutiny for years. despite the most recent publications recommending to apply non-operative treatment (exercise therapy, injections, drugs) instead of apm in this patient group, the expected decrease in number of operations is slower then expected. orthopaedic surgeons therefore seem unconvinced by the evidence to change practice. for this reason the investigators conducted an international survey amongst orthopaedic surgeons in which the investigators aimed to (1) determine the ability of orthopaedic surgeons to predict the outcomes of apm and physical therapy (pt) in middle aged patients with a non-obstructive meniscal tear, and (2) to determine which patient factors direct surgeons towards apm and towards pt.

Eligibility criteria:
in this survey the investigators invited orthopaedic surgeons and residents from both the netherlands and australia to complete a meniscus survey, including a random sample of patients from the escape trial. the in-/exclusion criteria are listed below. inclusion criteria: * patients between 45 and 70 years of age at presentation. * a meniscal tear visualized on mri. the meniscal tear can either be isolated or combined with a partial asymptomatic anterior cruciate ligament (acl) injury or an asymptomatic degenerative acl shown on mri with no abnormal clinical findings (a negative lachman test and pivot shift). * mental competence. * willingness to comply with follow up schedule. * written informed consent. exclusion criteria: * knee locking or trauma leading to acute surgery. * one of the following associated injuries on the index knee: * a symptomatic partial acl rupture or any total acl rupture determined by clinical examination (positive lachman test and/or positive pivot shift) and shown on mri; * a complete posterior cruciate ligament (pcl) injury; * cartilage change down to bone; grade 4 of the kellgren lawrence grading scale for osteoarthritis visualized on x-ray; * an injury to the lateral/posterolateral ligament complex with significantly increased laxity. * a history of knee surgery other than diagnostic arthroscopy on the index knee. * tumors on mri suspected for a malignancy. * obese patients with body mass index (bmi) \> 35. * asa 4-5 patients which can severely interfere with rehabilitation. * general disease that effects physical function or systemic medication/abuse of steroids (e.g., rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout, pseudogout) * any other medical condition or treatment interfering with the completion or assessment of the trial, e.g. contraindications to mri or surgery. * drugs or alcohol abuse.
a study of the efficacy and safety of topiramate in obese, type 2 diabetic patients inadequately controlled on sulfonylurea therapy

Conditions: Obesity; Diabetes Mellitus, Type 2; Diabetes Mellitus, Adult-Onset

Summary: the purpose of this study is to compare the effectiveness and safety of topiramate with placebo in the treatment of obesity and type 2 diabetes mellitus in patients who have failed on sulfonylurea therapy.

topiramate is a medication for the treatment of seizures, but not approved for the treatment of obesity. this is a randomized, double-blind, placebo controlled study to evaluate the effectiveness and safety of topiramate in type 2 diabetic patients with obesity who have failed on treatment with sulfonylurea. after a 4-week enrollment phase and 8-week titration phase, patients receive either topiramate (96, 192, or 256 mg twice daily) or placebo for 44 weeks, followed by a 6-week follow-up phase. assessments of effectiveness include body weight, hemoglobin type a1c \[hba1c\] (a measurement of average blood sugar level over several months), body mass index (bmi), fasting plasma glucose (fpg) level, fasting lipid profile, fasting insulin, uric acid level, blood pressures, and health related quality of life (hrqol) measures. safety evaluations, including incidence and severity of adverse events, hypoglycemic episodes, clinical laboratory results such as the liver enzymes, and vital signs, are performed throughout the study. the study hypothesis is that topiramate will be effective in the treatment of type 2 diabetes through weight reduction. during the initial 8-weeks, oral doses taken twice daily of topiramate or placebo will be gradually increased to target doses (either 96 milligrams\[mg\], 192mg, or 256mg daily); the dose will be maintained for 44 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes, receiving only second generation sulfonylurea therapy (may include: glipizide, gliclazide, glimepiride, glibenclamide/glyburide, and gliquadone) for at least 4 months and on stable dose for at least 2 months * body mass index \>= 27 and \< 50 * hba1c \< 11% at enrollment * diagnosed hypertension or hyperlipidemia must be controlled * female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception (requires negative pregnancy test) exclusion criteria: * known contraindication or hypersensitivity to topiramate or sulfonylurea therapy * pregnancy or women who are nursing or plan to become pregnant during the study * diagnosed with type 1 diabetes * history of severe or recurrent hypoglycemic episodes * treatment with any antidiabetic agent other than sulfonylurea

Keywords: obesity type 2 diabetes mellitus hba1c sulfonylurea topiramate adult-onset diabetes mellitus (aodm)
diabetes care for breast cancer patients

Conditions: Breast Cancer; PreDiabetes; Type 2 Diabetes

Summary: the goal of this study is to find a new way to make diabetes care better for patients with breast cancer and diabetes who are currently receiving cancer treatment. we will have two groups, the researchers will decide who is in which group. one group will be working with a nurse who is trained in diabetes care while the other does not. this will allow the investigators to see if having a trained nurse as part of the care team can help improve the care the patients receive.

the present study aims to develop a stakeholder-engaged nurse practitioner (np)-led intervention to improve diabetes care for patients with breast cancer and diabetes who are undergoing cancer treatment. this is a pilot feasibility study, in which we will use a quasi-experimental pre-post design with non-randomized intervention and control groups. in this feasibility study, the investigators will first enroll 38 eligible patients for the control group and collect effectiveness measures at baseline and follow-up (end of chemotherapy or other cancer treatment, \~12 weeks). through chart review, the investigators will document cancer treatment regimen completion at follow-up. the investigators will then enroll 38 patients for the intervention group, collecting the effectiveness and implementation outcomes at the end of their treatment (\~12 weeks). the main hypothesis that will be tested in this pilot study is that a nurse practitioner embedded in the oncology team who is trained in diabetes management may successfully manage diabetes during active cancer care for patients undergoing cancer treatment.

Eligibility criteria:
inclusion criteria: * newly diagnosed invasive cancer * plan to receive neo-adjuvant or adjuvant chemotherapy, targeted therapy, hormonal therapy, or radiation at weill cornell medicine (wcm) * age 18+ years * pre-diabetes or type 2 diabetes. treatment with antidiabetic medication or * hba1c greater than or equal to 5.7 or * random glucose greater than or equal to or * fasting blood glucose greater than or equal to 100 exclusion criteria: * patients receiving hospice care * type 1 diabetes
effect of compression garments on exercise performance following acute high intensity exercise

Conditions: Muscle Damage

Summary: to examine the influence of compression garments manufactured with far-infrared technology on exercise performance during and after repeated eccentric isokinetic muscle actions of the leg extensors.

participants: eighty recreationally active (1-5 hrs per week) healthy participants between the ages of 18 - 35 will visit the neuromuscular research laboratory on 6 separate occasions, with 4 of those occasions also requiring a visit to health services for a blood draw. procedures (methods): during pre-screening, each participant will complete an informed consent document, a health history questionnaire, and have their stature and body mass assessed. a familiarization session will then be conducted on a separate day where all participants will practice the strength assessment, eccentric isokinetic protocol, and ultrasound assessments. participants will be assigned to 1 of the 4 treatment groups based on their initial maximal isometric strength values using a matched-participants design. the first experimental session will then begin 2-10 days later, where the participants will perform the repeated eccentric exercise protocol (10 sets of 15 eccentric contractions 210 deg/sec with 3 min of rest between sets) with the non-dominant leg following a 60 min rest period where they will wear the apparel and perform a 5 min warm-up on a cycle ergometer. follow-up blood draws and strength and ultrasound assessments will be obtained at 24 and 48 hours post-exercise. each participant will also complete a visual analog scale at baseline, 24, 48, and 72 hours post-exercise to examine perceived muscle soreness.

Eligibility criteria:
inclusion criteria: * cohort of adult males \& females * participant is between the ages of 18-35 * healthy, recreationally active (1-5 hours per week) * participant has provided written and dated informed consent to participate in the study * participant is apparently healthy and free from disease, as determined by a health history questionnaire * participant agrees to abstain from smoking, caffeine (4hrs prior), tobacco (24hrs prior), and alcohol (24 hrs) before testing days * participant agrees to abstain from exercise 24 hours prior to each testing visit and after 72 hours of the induced exercise damage * participant will refrain from the use of non-steroidal anti-inflammatory drugs (nsaids) and protein supplementation 24 hours before the exercise testing protocol, as well as for the 72 hour period following the exercise testing protocol. exclusion criteria: * participant is using, or has used one of the following dietary supplements within 12 weeks prior to enrollment: beta-alanine, creatine, taurine, or any supplemental antioxidants (acai, pomegranate, beet juice). * participant is in, or has participated in another clinical trial within 6 weeks prior to enrollment * participant has a known allergy or sensitivity to test product (determined from health history questionnaire and consent form)

Keywords: compression, isokinetic, far-infrared
patients with diabetic neuropathy who receive physiotherapy treatment will have a decrease in diabetic foot ulcers

Conditions: Diabetic Foot Ulcer; Diabetic Neuropathy Peripheral

Summary: this study evaluates the effects of a physiotherapy protocol (manual therapy and exercise) in the prevention of diabetic foot ulcers in patients with diabetic neuropathy. a group of participants will receive a physiotherapy protocol added to their usual medical treatment and the other group will not receive physiotherapy treatment.

neuropathic diabetic patients present alterations in joint mobility, plantar pressures and ankle and foot function, characteristics related to the development of ulcers. in previous studies, it has been observed that physiotherapy protocols have produced improvements in joint mobility, magnitude of plantar pressures, distribution of plantar pressures, and improved function in the ankle and foot. a 12-week progressive physiotherapy protocol composed of manual therapy and exercise could produce changes in foot and ankle characteristics in diabetic neuropathic patients related to tissue damage, resulting in a reduction in ulcerations.

Eligibility criteria:
inclusion criteria: * participants with diabetes mellitus type 1 or type 2 * patients with diabetic neuropathy * patients with no previous history of ulcers * patients with no previous history of lower limb amputations exclusion criteria: * patients with neurological or orthopedic problems that make walking difficult (spasticity, cerebral palsy, poliomyelitis, rheumatoid arthritis) * severe vascular complications (arterial or venous ulcers) * patients with critical ischemia * patient who need walking aids (canes, crutches, splints etc.) * patients with a history of neuropathy with different etiology from diabetes mellitus. * patients with peripheral nervous lesions (traumatic origin, associated with surgical procedures, compression of spinal roots, plexus palsy, herpes zoster, polyradiculopathy, etc.)

Keywords: prevention physiotherapy diabetic foot ulcer exercise therapy manual therapy
multicentre study to assess changes in bone mineral density of the switch from tenofovir to abacavir in hiv-1-infected subjects with loss of bone mineral density

Conditions: HIV

Summary: most of studies have not found any consistent drug-specific association with bone loss and controversial data with respect the effect of protease inhibitors (pis) have been published. the more evident finding with respect to this issue is the more pronounced decrease of bone mineral density (bmd) in patients during the first weeks of receiving a tenofovir (tdf)-containing regimen, probably by the effect of tdf on phosphorus balance and vitamin d metabolism.

the prevalence of osteoporosis in hiv-infected patients could be more than three times greater compared with hiv-uninfected subjects, according to the results of a meta-analytical review of cross-sectional published studies. the analysis includes data from 884 hiv-infected patients and 654 hiv-uninfected controls. sixty-seven percent of hiv population had reduced bone mineral density (bmd), of whom 15% had osteoporosis (or of 6.4 and 3.7, respectively, compared with hiv-uninfected controls). in the same meta-analysis, when authors evaluated the role of antiretroviral therapy (art) on bmd, comparing 202 antiretroviral-naive with 824 art-treated patients, patients on treatment had a 2.5-fold increased odds of prevalent reduced bmd and osteoporosis. and finally, when 410 non-protease inhibitor (pi)-treated hiv patients were compared with 791 patients receiving a pi-containing regimen, those on pis had increased odds of reduced bmd and osteoporosis. as well, other studies support data of an impaired bmd in hiv-infected patients after starting antiretroviral therapy. these results let us confirm that hiv itself and antiretroviral therapy contribute to decrease the bmd. however, most of studies have not found any consistent drug-specific association with bone loss and controversial data with respect the effect of pis have been published. the more evident finding with respect to this issue is the more pronounced decrease of bmd in patients during the first weeks of receiving a tenofovir (tdf)-containing regimen, probably by the effect of tdf on phosphorus balance and vitamin d metabolism.

Eligibility criteria:
inclusion criteria: 1. adult patients (=/+18 years old) having a diagnosis of hiv-1 infection. 2. current haart including tenofovir plus emtricitabine/lamivudine plus a pi, a nnrti or raltegravir started at least 12 months before. 3. t-score ≤-2 measured by dexa (within the last 6 months). 4. maintained undetectable plasma hiv-1 rna (vl \< 50 copies/ml) for at least 12 months. 5. absence of suspected or documented resistance mutations in the rt associated to abacavir. 6. voluntary written informed consent. exclusion criteria: 1. history of intolerance, toxicity or virological failure to abacavir. 2. hla b\*5701 positive. 3. secondary osteoporosis/osteopenia (vitamin d or testosterone deficit, thyroid disease, ...) 4. therapy with biphosphonates within the last 12 months.

Keywords: tenofovir hiv-infection bmd osteoporosis osteopenia
clinical study of the solo+ tympanostomy tube device

Conditions: Ear Infection; Otitis Media

Summary: the objective of this study is to evaluate the safety and performance of the solo+ tympanostomy tube device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure

the study will be a multi-site, prospective, treatment-only study of the solo+ tympanostomy tube device. patients will already have a scheduled tympanostomy procedure.

Eligibility criteria:
inclusion criteria: * listed for bilateral tympanostomy tube insertion exclusion criteria: * anatomy that precludes sufficient visualisation of both the left and right eardrum * narrow ear canals * anatomy that precludes safe access to both the left and right eardrum * membrane \>25% sclerosis * congenital or craniofacial abnormalities * no available baseline audiometry and tympanometry
investigation of the effectiveness of upper limb exercise in copd patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of the study is to investigate the efficacy of upper limb exercise training in chronic obstructive pulmonary disease (copd) patients. for the purpose of the study, a controlled trial will be conducted within respiratory clinic of nicosia general hospital. the sample will be divided in two groups. the intervention group will participate in a pulmonary rehabilitation program which includes upper and lower extremities exercises, with addition of arm ergometer. the second group (control group) will participate in the same program but without arm ergometer training. the study's hypothesis is that the intervention group will improve the outcome measures significantly better than the control group.


Eligibility criteria:
inclusion criteria: * diagnosis of copd confirmed by clinical examination and a pulmonary function test * stable clinical condition (without recent respiratory system infections or any exacerbation of the disease) * patients must be willing to re evaluate at the end of the study * patients must be willing to give written consent for their participation in the study exclusion criteria: * age \< 18 years old * unstable cardiac disease * musculoskeletal and neurological diseases that could affect exercise performance or preclude exercise * patients of copd final stage or other serious disease final stage * significant cognitive or psychiatric impairment that would lead to an inability to follow simple commands in a group setting
sonication of syndesmotic screws

Conditions: Periimplant Infection

Summary: peri-implant infections are severe complications after internal fracture fixation surgery. detection of causative agents of orthopedic implant-associated infections (oiai) is demanding. several authors reported increased identification rates of bacterial prevalence using different sonication procedures compared to standard tissue cultures samples, especially for low grade infections. on the author hand, contamination of implants without clinical signs of infection is reported in up to 30% during implant removals after uneventful fracture healing. the raised general questions are: 1.) is a positive microbiological finding the result of contamination during the index surgery or during implant removal? 2.) does contaminated implants without clinical or serological signs of infection have a pathological value?

in this prospective case study, the detection rates of different diagnostic tools for peri-implant contaminations during removal of syndesmotic screws should be compared and the clinical consequence of positive findings evaluated in follow up investigations up to 6 months. patients with ankle fractures (weber b and c) treated operatively in our department by open reduction and internal fixation with plates and additional syndesmotic screw should be included. after patients´ informed consent, several microbiological samples should be taken for further microbiological analysis during the standard syndesmotic screw removal 6-8 weeks after the index surgery. at follow up of two weeks after screw removal a clinical examination and serological analysis for infection will be performed. the endpoint of study is fracture healing at six months.

Eligibility criteria:
inclusion criteria: * patients with syndesmotic screw removal after open reduction and internal fixation with plates and additional syndesmotic screw of ankle fractures (weber b or c) in our department. exclusion criteria: * patients with immunosuppressive diseases or therapies, * pregnant women * patients with pre-operations on the same ankle-joint * patients with initial surgery for fracture fixation in other hospitals.

Keywords: sonication
clbs119 for repair of covid-19 induced pulmonary damage

Conditions: Covid-19

Summary: this clinical trial will explore the safety and potential efficacy of clbs119 for the repair of covid-19 induced pulmonary damage in adults.

this open-label clinical trial will explore the safety and potential efficacy of peripheral blood derived autologous cd34+ cells for the repair of covid-19 induced pulmonary damage in adults. eligible subjects will receive a single administration of clbs119.

Eligibility criteria:
inclusion criteria: * initial diagnosis with covid-19 based on nasopharyngeal, oropharyngeal, or tracheobronchial aspirate sars cov-2 rt-pcr test * receiving or received ventilatory support for covid-19 pneumonia/ards * evidence for ongoing pulmonary involvement based on p/f ratio \<300 * able to provide informed consent exclusion criteria: * immunocompromised or current use of immunosuppressive agents other than corticosteroids * history of autoimmune disease * evidence of multiorgan failure * subject is pregnant or lactating at the time of signing the consent * participation in any other clinical trial of an experimental treatment for covid-19 * history of sickle cell disease

Keywords: pneumonia covid sars-cov-2 pulmonary inflammation respiratory distress syndrome lung diseases lung injury respiratory tract diseases respiratory insufficiency ards pandemic corona virus infection coronavirus
treatment adherence to injectable methotrexate in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the aim of this study is to evaluate, at 6 months, the rate of patients whose adherence to injectable mtx remained strong or improved according to patient-reported outcome.


Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years old) * patients with a diagnosis of ra as confirmed by the acr/eular (2010) classification criteria for rheumatoid arthritis * patients: * currently treated with oral mtx and requiring a switch to an injectable mtx\* or * currently treated with an injectable mtx\* and eligible for a change of mtx injection device\* * patients informed about and accepting the computer processing of their medical data and their right of accesss and correction. exclusion criteria: - patients who refuse to participate in the study or are unable to fill out the patient diary. \*on the basis of the products marketed at the time of submission of the study to oversight authorities (méthotrexate biodim®, metoject® and imeth®).

Keywords: methotrexate treatment adherence